On November 2, Crowell hosted an in-person roundtable discussion, featuring government officials, industry experts and other stakeholders, to discuss the development of artificial intelligence (AI) and machine learning (ML) systems and tools in the healthcare sector as well as the government’s role in regulating such technology. Policy makers, thought leaders, healthcare innovators, and business executives came together for a lively and engaging conversation. 

During the first session led by Crowell Health Solutions (CHS) Managing Director and Partner at Crowell & Moring Jodi Daniel, panelists discussed recent federal regulatory and legislative developments to govern health AI. Earlier that week, the Administration had issued an Executive Order (EO) to advance the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” Danielle Carnival, Deputy Assistant to the President for the Cancer Moonshot and Deputy Director for Health Outcomes at the Office of Science and Technology Policy (OSTP), discussed the EO’s health care-specific provisions and highlighted the President’s commitment to protect individuals’ privacy and advance health equity and civil rights. Aaron Cummings, co-chair of Crowell & Moring Government Affairs, provided insight about Congress’ plan to regulate AI and told participants to expect House and Senate hearings in the coming months, specifically focused on health data privacy issues and potential proposals to revise the Health Insurance Portability and Accountability Act (HIPAA) framework.

Nigel Cory, Associate Director of Trade Policy of the Information Technology and Innovation Foundation spoke about the intersection of international and U.S. policy on AI, specifically commenting on data sharing between countries in addition to the European Union’s General Data Protection Regulation (GDPR). Cory emphasized the role of the private sector in government discussions to regulate AI, stating that the private sector should play a foundational role in the development of technical standards. The European Union has been a leader internationally in regulating AI and most recently reached an agreement on the AI Act among key policymakers. Patty Wu, Crowell & Moring International Vice President and Managing Director, stated that international companies can look at specific use cases while discussing and analyzing policy issues in order to harness AI for good.

The second session, led by CHS Director and Crowell & Moring Counsel Roma Sharma, featured the perspectives of healthcare stakeholders from private industry and focused on organizations’ current and future use of health AI. Ms. Sharma spoke about the importance of organizational focus on ethical use of AI, ensuring that such technologies are trusted by patients and consumers, and establishing policy guardrails to prevent bias and discrimination. Dale Kadlec, Lead Counsel of U.S. Health and Life Sciences at Microsoft, spoke about the company’s development and use of Microsoft’s responsible use of AI principles and the ways in which Microsoft’s AI services provide value in health care delivery and administration.

Christian Wickert, Head of Global Digital Policy of Merck KGaA stated that the company organized a digital health panel, comprised of representatives from the private sector, academia, and patient groups, to examine privacy and bias issues when using health AI tools. Wickert stated that transparency is one of the most important elements for development of AI systems and technologies. Ashley Southerland, Vice President and Deputy General Counsel of Homeward Health, explained that organizations’ use of health AI must foremost consider harm and other impact on patients. Ms. Southerland stated that partnerships with local individuals and organizations can help to build trust among a rural patient population.

Policy frameworks have become increasingly important as AI/ML technology develops rapidly, with industry experts wary of the pace of technological development outpacing guardrails and regulations. Companies and organizations continue to track international and domestic policy developments and implement internal guardrails governing data use and use of AI tools. Technological and regulatory developments in AI/ML will continue to move rapidly.

The roundtable discussion on AI was co-organized by CHS, Crowell & Moring International, and Crowell & Moring Government Affairs. CHS is a strategic consulting firm focused on helping clients to pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care.   

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Photo of Jodi G. Daniel Jodi G. Daniel

Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She…

Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm’s Digital Health Practice and provides strategic, legal, and policy advice to all types of health care and technology clients navigating the dynamic regulatory environment related to technology in the health care sector to help them achieve their business goals. Jodi is a contributor to the Uniform Law Commission Telehealth Committee, which drafts and proposes uniform state laws related to telehealth services, including the definition of telehealth, formation of the doctor-patient relationship via telehealth, creation of a registry for out-of-state physicians, insurance coverage and payment parity, and administrative barriers to entity formation.

Photo of Roma Sharma Roma Sharma

Roma Sharma is an associate in Crowell & Moring’s Washington, D.C. office and a member of the firm’s Health Care Group. Roma primarily works with health care clients seeking to comply with regulations for state and federal health care programs, health care anti-fraud…

Roma Sharma is an associate in Crowell & Moring’s Washington, D.C. office and a member of the firm’s Health Care Group. Roma primarily works with health care clients seeking to comply with regulations for state and federal health care programs, health care anti-fraud and abuse laws, and licensing laws.

Roma’s work incorporates her Master of Public Health degree in Health Policy as well as her past experiences as an extern at the Office of the General Counsel at the American Medical Association and as an intern at the Illinois Office of the Attorney General, Health Care Bureau.

Photo of Allison Kwon Allison Kwon

Allison Kwon supports Crowell Health Solutions, a strategic consulting firm affiliated with Crowell & Moring, to help clients pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health…

Allison Kwon supports Crowell Health Solutions, a strategic consulting firm affiliated with Crowell & Moring, to help clients pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care. She is a health care policy consultant in the Washington, D.C. office.